MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION EXTERNAL BATTERY; BATTERY PACK

Catalog Number 293001-001

Device Problems Battery Problem (2885); Power Problem (3010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2021

Event Type  malfunction  

Manufacturer Narrative

The companion external battery has been returned to syncardia for evaluation.The results will be submitted in a follow-up mdr.(b)(4).

Event Description

The companion external battery was not supporting a patient.The customer, a syncardia certified hospital, reported that companion external battery did not charge in the companion 2 driver and the driver display showed a red x over the battery icon.

Manufacturer Narrative

The customer-reported issue was confirmed as the companion 2 driver display showed a red x over the battery icon when the external battery was placed in the driver.During evaluation, the external battery was not able to charge and could not communicate with the battery's system management (smbus).This indicates that the external battery was too far depleted to be recognized by the driver or accept a charge.The root cause was most likely a deep discharge event leading to a permanent fault by external battery's internal safety circuitry.Although the cause of the deep discharge event could not be conclusively determined, it is possible the external battery was stored for long periods of time without connecting to a power source.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.(b)(4) follow-up report 1.

• Brand Name: SYNCARDIA COMPANION EXTERNAL BATTERY
• Type of Device: BATTERY PACK
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 11832375
• MDR Text Key: 253199305
• Report Number: 3003761017-2021-00092
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 293001-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Date Manufacturer Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1